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High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

Primary Purpose

Renal Failure, Chronic Kidney Disease Requiring Chronic Dialysis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Soy protein isolate

Whey protein isolate

About this trial

This is an interventional basic science trial for Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old or older
diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial
3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial
All participants have the ability to provide signed informed consent
have not been newly diagnosed
not present with symptomatic infection of COVID-19
have no dietary restriction
no food allergies
no chewing/swallowing difficulties

Exclusion Criteria:

CKD patient stages 1-4.
CKD patient undergoing peritoneal hemodialysis.
In isolation due to COVID-19 or other infectious disease
Adult pregnant and/or lactating for the duration of the study.
Any other renal disease autoimmune or otherwise.
Use of other IP within 3 months prior of the eligibility screening.

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Whey protein isolate

Soy protein isolate

Arm Description

Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Outcomes

Primary Outcome Measures

C-reactive protein

Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

IL-6

Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

Normalized protein catabolic rate

Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.

Secondary Outcome Measures

Isoflavones - Serum values of Genistin and Daidzin

Collection of serum isoflavones (genistin and daidzin) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via HPLC.

Uremic toxins - serum p-cresol sulfate and indoxyl sulfate

Collection of serum uremic toxins (p-cresol sulfate and indoxyl sulfate) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via LC/MS.

Serum Amino acid profiles of essential and non-essential amino acids

Collection of serum amino acid profile of essential and non-essential amino acids to identify a change from pre-post to analyze the effect amino acids had on inflammation markers that will be assessed via LC/MS.

Malnutrition Inflammation Score

Assessment of malnutrition at baseline and post-intervention to determine nutritional status. There are a total of 10 questions that participants will answer. Scores are from as low as 0 to as high for 3 for each question. A score of 0 indicates normal whereas a score of 30 indicates severe malnutrition.

Full Information

NCT ID

NCT05227755

First Posted

December 21, 2021

Last Updated

April 4, 2023

Sponsor

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT05227755

Brief Title

High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

Official Title

High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2022 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators propose to determine the impact of high-protein beverages on protein status and inflammation markers among CKD patients undergoing hemodialysis. A 12-week double-blind randomized cross-over trial will be used in which participants (n=22) will consume a 4-ounce high protein supplement with either whey (20 g total protein) or soy (20 g total protein). Outcomes of interest include serum urea nitrogen and inflammation markers (CRP and IL-6). The findings will contribute to the knowledge gap regarding the effect of different protein types in CKD populations which can be translated to the development of affordable supplements to prevent malnutrition in adults with non-communicable diseases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure, Chronic Kidney Disease Requiring Chronic Dialysis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This is a 12-week interventional, double-blind randomized controlled crossover clinical trial designed to evaluate the impact of whey (control) and soy (intervention) protein isolate oral supplements on protein status and inflammation markers.

Masking

ParticipantInvestigator

Masking Description

A third party vendor will provide the coded samples. The vendor will only reveal the actual products once the study has ended and analysis has occurred.

Allocation

Randomized

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Whey protein isolate

Arm Type

Active Comparator

Arm Description

Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Arm Title

Soy protein isolate

Arm Type

Experimental

Arm Description

Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Soy protein isolate

Intervention Description

Participants will receive 120 mls of soy protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Whey protein isolate

Intervention Description

Participants will receive 120 mls of whey protein isolate (total of 20 g protein) to consume 3x/week after dialysis treatment for 4 weeks.

Primary Outcome Measure Information:

Title

C-reactive protein

Description

Collection of serum C-reactive protein to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

Time Frame

Up to 12 weeks of the study

Title

IL-6

Description

Collection of serum IL-6 to identify a change from pre-post to analyze the effect protein isolates had on inflammation markers.

Time Frame

Up to 12 weeks of the study

Title

Normalized protein catabolic rate

Description

Analysis of nPCR to identify a change from pre-post to analyze the effect protein isolates had on nPCR.

Time Frame

Up to 12 weeks of the study

Secondary Outcome Measure Information:

Title

Isoflavones - Serum values of Genistin and Daidzin

Description

Collection of serum isoflavones (genistin and daidzin) to identify a change from pre-post to analyze the effect soy protein isolate had on inflammation markers that will be assessed via HPLC.

Time Frame

Up to 12 weeks of the study

Title

Uremic toxins - serum p-cresol sulfate and indoxyl sulfate

Description

Time Frame

Up to 12 weeks of the study

Title

Serum Amino acid profiles of essential and non-essential amino acids

Description

Time Frame

Up to 12 weeks of the study

Title

Malnutrition Inflammation Score

Description

Time Frame

Up to 12 weeks of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old or older diagnosed with stage 5 CKD for at least 3 months prior to the starting date of the trial 3 sessions of hemodialysis per week for at least three months prior to the starting date of the trial All participants have the ability to provide signed informed consent have not been newly diagnosed not present with symptomatic infection of COVID-19 have no dietary restriction no food allergies no chewing/swallowing difficulties Exclusion Criteria: CKD patient stages 1-4. CKD patient undergoing peritoneal hemodialysis. In isolation due to COVID-19 or other infectious disease Adult pregnant and/or lactating for the duration of the study. Any other renal disease autoimmune or otherwise. Use of other IP within 3 months prior of the eligibility screening.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeanette M Andrade, PhD

Phone

3522943975

jandrade1@ufl.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Danielle Aycart, MS

Phone

3522943975

danielle.aycart@ufl.edu

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeanette M Andrade, PhD

Phone

352-294-3975

jandrade1@ufl.edu

12. IPD Sharing Statement

Plan to Share IPD

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High-protein Oral Supplement Improves Normalized Protein Catabolic Rate and Inflammation Markers

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